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Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke.

ABSTRACT: One of the most effective current approaches to preventing stroke events is the reduction of lifestyle risk factors, such as unhealthy diet, physical inactivity and smoking. In this study, we assessed the efficacy and usability of the phone-based Computer-aided Prevention System (CAPSYS) in supporting the reduction of lifestyle-related risk factors.A single-centre two-arm clinical trial was performed between January 2013 and February 2014, based on individual follow-up periods of six months with 94 patients at high risk of stroke, randomly assigned to an intervention group (IC: 48; advised to use the CAPSYS system) or a standard care group (SC: 46). Study parameters, such as blood pressure, blood values (HDL, LDL, HbA1c, glycaemia and triglycerides), weight, height, physical activity as well as nutrition and smoking habits were captured through questionnaires and medical records at baseline and post-intervention and analysed to detect significant changes. The usability of the intervention was assessed based on the standardised System Usability Scale (SUS) complemented by a more system-specific user satisfaction and feedback questionnaire.The statistical evaluation of primary measures revealed significant decreases of systolic blood pressure (mean of the differences = -9 mmHg; p = 0.03; 95% CI = [-17.29, -0.71]), LDL (pseudo-median of the differences = -7.9 mg/dl; p = 0.04; 95% CI = [-18.5, -0.5]) and triglyceride values (pseudo-median of the differences = -12.5 mg/dl; p = 0.04; 95% CI = [-26, -0.5]) in the intervention group, while no such changes could be observed in the control group. Furthermore, we detected a statistically significant increase in self-reported fruit and vegetable consumption (pseudo-median of the differences = 5.4 servings/week; p = 0.04; 95% CI = [0.5, 10.5]) and a decrease in sweets consumption (pseudo-median of the differences = -2 servings/week; p = 0.04; 95% CI = [-4, -0.00001]) in the intervention group. The usability assessment showed that the CAPSYS system was, in general, highly accepted by the users (average SUS score: 80.1).The study provided encouraging results indicating that a computerised phone-based lifestyle coaching system, such as CAPSYS, can support the usual treatment in reducing cerebro-cardiovascular risk factors and that such an approach is well applicable in practice.ClinicalTrials.gov Identifier: NCT02444715.

SUBMITTER: Spassova L

PROVIDER: S-EPMC4748685 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke.

Spassova Lübomira L Vittore Debora D Droste Dirk W DW Rösch Norbert N

BMC neurology 20160209

<h4>Background</h4>One of the most effective current approaches to preventing stroke events is the reduction of lifestyle risk factors, such as unhealthy diet, physical inactivity and smoking. In this study, we assessed the efficacy and usability of the phone-based Computer-aided Prevention System (CAPSYS) in supporting the reduction of lifestyle-related risk factors.<h4>Methods</h4>A single-centre two-arm clinical trial was performed between January 2013 and February 2014, based on individual f ...[more]

PMID: 26861865

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Project description:BackgroundLack of compliance to medication and uncontrolled risk factors are associated with increased risk of recurrent stroke and acute coronary syndrome in patients with recent stroke. Multimodal patient education may be a strategy to improve the compliance to medication and early adoption of nonpharmacological measures to reduce the vascular risk factor burden in patients with stroke. We thus aim to develop multilingual short messaging services (SMS), print, and audio-visual secondary stroke prevention patient education package. The efficacy of the package will be tested in a randomized control trial to prevent major cardiovascular and cerebrovascular events.MethodsIn the formative stage, intervention materials (SMS, video, and workbook) were developed. In the acceptability stage, the package was independently assessed and modified by the stakeholders involved in the stroke patient care and local language experts. The modified stroke prevention package was tested for implementation issues (implementation stage).ResultsSixty-nine SMS, six videos, and workbook with 11 chapters with 15 activities were developed in English language with a mean ± SD SMOG index of 9.1 ± 0.4. A total of 355 stakeholders including patients (24.8%), caregivers (24.8%), doctors (10.4%), nurses (14.1%), local language experts (2.8%), physiotherapists (13.2%), and research coordinators (9.8%) participated in 10 acceptability stage meetings. The mean Patient Education Material Assessment Tool understandability score in all languages for SMS, video scripts, and workbook was 95.2 ± 2.6%, 95.2 ± 4.4%, and 95.3 ± 3.6%, respectively. The patients [n = 20, mean age of 70.3 ± 10.6 years and median interquartile range (IQR) baseline NIHSS 1 (0-3)] or the research coordinators (n = 2) noted no implementation issues at the end of 1 month.ConclusionAn implementable complex multilingual patient education material could be developed in a stepwise manner. The efficacy of the package to prevent major adverse cardiovascular events is being tested in the SPRINT INDIA study.

Project description:BACKGROUND:Real-world studies have indicated that adherence is important for guaranteeing medication effectiveness. Few studies have tested the feasibility and efficacy of WeChat-based improvement services, via mobile phone, in secondary prevention-specific follow-up among discharged stroke patients. OBJECTIVE:We evaluated a quadruple-domain, WeChat-based service for ischemic stroke secondary prevention designed to improve treatment adherence of discharged patients. This service focuses on sending reminders for drug use, blood pressure recording, and glucose recording; it also records medication use. We compared the endpoint event rate between WeChat self-monitoring and traditional monitoring. METHODS:A cohort study was used to determine the feasibility of a physician-assisted, WeChat-based improvement service and follow-up self-monitoring platform for the secondary prevention of ischemic stroke. The platform was developed by the Peking University Third Hospital based on the information-motivation-behavioral skills model. The overall adherence rate was calculated as the proportion of medication doses verified via uploading. The ischemic endpoint event rate and medication noncompliance rate were compared between traditional prevention monitoring and WeChat self-monitoring. Factors influencing adherence were summarized. RESULTS:The 1-year follow-up event rate of the WeChat self-monitoring group was 11.9% (12/101), which was less than that of the traditional group (21/157, 13.4%). Compared with the traditional group, the risk ratio of the WeChat group was 0.983 (95% CI 0.895-1.080); this difference was not noted to be significant. The 1-year medication noncompliance ratio tended to be lower in the WeChat monitoring group (3/101, 3.0%) than in the traditional group (11/157, 7.0%; ?2=1.9, df=1, P=.16). Of the platform registry participants, 89.7% (210/234: 167 hospital-based and 43 community-based participants) adhered to inputting information into WeChat for 8-96 weeks. The average adherence time was 16.54 (SD 0.80, range 2-24) months. The average decrease in adherence was 4 participants (1.1%) per month. Being a member of a community-based population was an influencing factor for good adherence at the 2-year follow-up (OR 2.373, 95% CI 1.019-5.527, P=.045), whereas transient ischemic attack was an influencing factor for poor adherence at the 2-year follow-up (OR 0.122, 95% CI 0.016-0.940, P=.04). CONCLUSIONS:Use of WeChat self-monitoring showed a trend of increasing medication compliance and decreasing ischemic endpoint event rate compared with traditional monitoring. However, there were ceiling effects in the outcomes, and a relatively small sample size was used. Male participants displayed better adherence to WeChat self-monitoring. The community-based population displayed good adherence when using WeChat self-monitoring. TRIAL REGISTRATION:ClinicalTrials.gov NCT02618265; https://clinicaltrials.gov/ct2/show/NCT02618265.

Dataset Information

Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke.

Publications

Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke.

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